Legalize2012/725/EU: Commission Implementing Decision of 22 November 2012 authorising the placing on the market of bovine lactoferrin as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (Morinaga) (notified under document C(2012) 8390)
Article 1
Bovine lactoferrin as specified in Annex I may be placed on the market as a novel food ingredient for the uses defined and at the maximum levels established in Annex II, and without prejudice to the provisions of Regulation (EC) No 1925/2006 of the European Parliament and of the Council ([^E0004]) and Directive 2009/39/EC of the European Parliament and of the Council ([^E0005]).
Article 2
The designation of bovine lactoferrin authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘Lactoferrin from cow’s milk’.
Article 3
This Decision is addressed to Morinaga Milk Industry Co., Ltd, 33-1, Shiba 3-chome, Minato-ku, Tokyo 108-8384, Japan.
ANNEX I
SPECIFICATIONS OF BOVINE LACTOFERRIN
Definition
Bovine lactoferrin (bLF) is a protein that occurs naturally in cow's milk. It is an iron-binding glycoprotein of approximately 77 kDa and consists of a single polypeptide chain of 689 amino acids.
bLF is isolated from skimmed milk or cheese whey via ion exchange and subsequent ultra-filtration steps. Finally it is dried by freeze drying or spraying and the large particles are sieved out.
Description: Virtually odorless, light pinkish powder
Physical-chemical properties of bovine lactoferrin
| Moisture | less than 4,5 % |
| Ash | less than 1,5 % |
| Arsenic | less than 2 mg/kg |
| Iron | less than 350 mg/kg |
| Protein | more than 93,0 % |
| of which bovine lactoferrin | more than 95,0 % |
| of which other proteins | less than 5,0 % |
| pH (2 % solution, 20 °C) | 5,2 to 7,2 |
| Solubility (2 % solution, 20 °C) | complete |
ANNEX II
USES OF BOVINE LACTOFERRIN (bLF)
| Food category | Maximum use levels of bLF |
|---|---|
| Infant formulae and follow on formulae (ready to drink) | 100 mg/100 ml |
| Foods on dairy basis intended for young children (ready to eat/drink) | 200 mg/100 g |
| Processed cereal food (solid) | 670 mg/100 g |
| Foods for special medical purposes | Depending on the needs of the individual up to 3 g/day |
| Beverages based on milk | 200 mg/100 g |
| Powdered drink mixes based on milk (ready to drink) | 330 mg/100 g |
| Beverages based on fermented milk (including yoghurt drinks) | 50 mg/100 g |
| Non-alcoholic drinks | 120 mg/100 g |
| Products based on yoghurt | 80 mg/100 g |
| Products based on cheese | 2 000 mg/100 g |
| Ice cream | 130 mg/100 g |
| Cakes and pastries | 1 000 mg/100 g |
| Candies | 750 mg/100 g |
| Chewing gum | 3 000 mg/100 g |
OJ L 43, 14.2.1997, p. 1.
EFSA Journal 2012; 10(7): 2811.
EFSA Journal 2012; 10(5): 2701.
[^E0004]: OJ L 404, 30.12.2006, p. 26.
[^E0005]: OJ L 124, 20.5.2009, p. 21.
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